Food and Drug Law Commons^™

Legal Discrimination Against Organ Transplant Candidates: Medicinal Marijuana And The Double-Edged Sword, 52 Uic J. Marshall L. Rev. 859 (2019), Kyle Jorgensen

UIC Law Review

No abstract provided.

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski

Brooklyn Law Review

Pharmaceutical companies advertise drugs directly to consumers via television and radio broadcast commercials, print advertisements, and the internet. Although broadcast advertisements are demonstrably unable to adequately convey risk information, a total ban on them would be too restrictive, and any regulation targeting these advertisements must withstand First Amendment scrutiny. The FDA’s recent attempts to modify its requirements for broadcast advertisements do not overcome these challenges. It is in the best interest of patients, doctors, the drug industry, and the government for Congress to authorize the FDA to regulate broadcast drug advertisements as limited calls to action, consisting of restricted product …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan

Articles

As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …

Exploring Legal And Policy Responses To Opioids: America's Worst Public Health Emergency, James G. Hodge Jr., Chelsea Gulinson, Leila F. S. Barraza, Walter G. Johnson, Drew Hensley, Haley R. Augur

South Carolina Law Review

No abstract provided.

A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse

Michigan Journal of International Law

Part I of this Article provides an overview of some of the key terms and provisions of Canada’s Cannabis Act. Part II looks at the Cannabis Act in the context of the International Drug Conventions, examining how the various convention provisions might apply, looking first at the Single Convention and then at the 1988 Convention and how that convention fits with Canadian constitutional provisions. Part III focuses on the international human rights framework and how the Cannabis Act might be viewed as compatible with international human rights law even where incompatible with the International Drug Conventions. This Part also offers …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

Fraud, Abuse, And Opioids, Stacey A. Tovino

Faculty Articles

This Article analyzes recent government enforcement actions involving two health care fraud and abuse authorities, including the federal Anti- Kickback Statute and the federal civil False Claims Act, in cases involving opioids. Part II of this Article examines recent government enforcement actions involving the federal Anti-Kickback Statute, which prohibits (among other conduct) the exchange of remuneration for opioid prescriptions, patient referrals for drug testing services, and patient referrals for addiction treatment services if such prescriptions or services are reimbursed in whole or in part by a federal health care program. Part III of this Article examines recent government enforcement actions …

Encouraging Food Safety Standard Negotiations In The One-Belt-One-Road Initiative, Yi Seul Kim

Cardozo International & Comparative Law Review

Participation and attendance in food safety negotiations such as Codex meetings are of critical importance. Common problems have existed throughout history in the area of food safety standards and their formulation regulations. First, there is a lack of interest by the public. Second, the public becomes interested only after a food safety crisis. Consequences are two-fold: with lack of public interest, governments often do not allocate enough budget and resources. Then, when the government turns to face the problem with a sudden spike in public interest, it is often too late. The situation becomes more of a crisis management, rather …

Commercial Speech Protection As Consumer Protection, Felix T. Wu

Articles

The Supreme Court has long said that “the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides.” In other words, consumers—the recipients or listeners of commercial speech—are the ones the doctrine is meant to protect. In previous work, I explored the implications of taking this view seriously in three contexts: compelled speech, speech among commercial entities, and unwanted marketing. In each of those contexts, adopting a listener-oriented approach leads to the conclusion that many forms of commercial speech regulation should receive far less First Amendment scrutiny than …

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

A Case For United States Overhaul Of Its Current Biotechnology Regulation Scheme Through The Implementation Of Biotechnology-Specific Legislation To Clarify Existing Uncertainties Seen In The Collective Framework, Jordan Emmert

Cardozo International & Comparative Law Review

The U.S. biotechnology regulatory framework, established by the 1986 Coordinated Framework and its 1992 Update, is outdated and insufficient to address modern biotechnology products, particularly genetically modified organisms (GMOs). While efforts such as the Obama Administration’s 2015 Memorandum and the 2016 Update aimed to modernize the system, they failed to resolve jurisdictional ambiguities and regulatory gaps, leading to inconsistent agency enforcement and public distrust. The note argues that updating the statutory framework is essential to align U.S. regulations with international norms, ensure public safety, and maintain global competitiveness.

Craft Beer And The Rising Tide Effect: An Empirical Study Of Sharing And Collaboration Among Seattle's Craft Breweries, Zahr K. Said

Lewis & Clark Law Review

This qualitative empirical research project studies Seattle’s craft brewing industry as a thriving entrepreneurial ecosystem that displays widespread collaboration and innovation. Drawing on data collected in 22 face-to-face formal interviews conducted with industry participants, the Article explores the community’s attitudes, practices, and norms with respect to collaboration and intellectual property (IP). It joins a growing body of qualitative empirical IP scholarship that maps misalignments between law and practice “on the ground,” seeking to offer a more accurate and pluralistic account of an innovative industry. The craft brewing community in Seattle cooperates extensively while continuing to compete actively for consumers. In …

Marijuana Legalization, Racial Disparity, And The Hope For Reform, Michael Vitiello

Lewis & Clark Law Review

The criminalization of marijuana is rooted in a deeply racist history and has devastated minority communities. Studies show that usage of the drug is consistent across racial groups, but arrests of minorities are nevertheless higher than arrests of white offenders. Indeed, those kinds of disparities have persuaded some voters and policy makers to support legalization of marijuana.

California’s initiative, Proposition 64, passed in November 2016 and is now being implemented statewide. Drafters of Proposition 64 were aware of the racial disparity in enforcement of marijuana laws and attempted to offer a remedy. This Article asks whether Proposition 64 can achieve …

A Hybrid Approach To Marijuana Federalism, Susan F. Mandiberg

Lewis & Clark Law Review

With the evident indulgence of the United States Department of Justice, states are jumping on the bandwagon of legalizing medicinal and recreational marijuana even though marijuana use is criminalized under the Federal Controlled Substances Act. The possibility that the federal government will at some point decriminalize marijuana use poses a challenge for the construction of a regulatory framework. In short, how should the states and the federal government divide regulatory responsibilities?

There has been significant academic discussion about possible regulatory frameworks to address this issue. Drawing upon existing federalism schemes in the environmental and natural resource area, this Article reviews …

Cannabis And Insurance, Francis J. Mootz Iii, Jason Horst

Lewis & Clark Law Review

Although many states have decriminalized or legalized cannabis, it remains a Schedule 1 drug under the federal Controlled Substances Act. The conflict between federal and state law presents many complicated issues, including problems relating to insurance coverage. Insurance law seeks to balance competing policy interests. On one hand, public policy supports reading insurance policies broadly to indemnify policyholders for their losses. On the other hand, public policy counsels against permitting insurance to indemnify (federally) illegal activity. In this Article, we explore some pressing issues arising from the conflict between these policy considerations and offer some analysis of the conflict in …

Reefer Madness In Federal Court: An Overview Of How Federal Courts Are Dealing With Cannabis Litigation And Why It Is Necessary To “Dig Into The Weeds”, Blake Marvis

Lewis & Clark Law Review

Litigation stemming from the state-legal cannabis industry has presented many unique questions for federal courts to grapple with. Can federal courts provide equitable relief to state-legal cannabis litigants, despite being in violation of federal law? Can workers in the state-legal cannabis industry sue their employers to recover required minimum wage under federal statutes? Is a contract that is made in a state-legal cannabis market automatically void? This Comment examines the precarious nature of state-legal cannabis litigation in federal courts through a dissection of how litigation has progressed. It also examines the framing of the arguments made in cannabis disputes. Although …

If It Looks Like A Duck: Equal Protection, Selective Prosecution, And Geographic Differences In The Federal Prosecution Of Marijuana Crimes Under The Controlled Substances Act, Zachary Nelson

Lewis & Clark Law Review

State legalization of marijuana for medical purposes has skyrocketed since California first authorized medical marijuana in 1996. Today, citizens in 33 states can use marijuana for medical purposes. While each state maintains distinct regulatory systems and eligibility requirements, the core result of these state medical marijuana programs is that citizens in 33 states can lawfully possess and use marijuana. Yet federal law makes any use of marijuana illegal under the Controlled Substances Act (CSA). Through the Supremacy Clause, this illegality is controlling and preemptive in every state; that is, even if a state makes marijuana legal for certain purposes, an …

Cannabis Law, The Constitution, And The Aba Model Rules, Hayley Hollis

Lewis & Clark Law Review

Though a growing number of states have legalized recreational or medical cannabis use, cannabis is still categorized as a Schedule I substance under the Controlled Substances Act, and its use, possession, and cultivation are federal offenses. This conflict between state and federal law creates a unique challenge for the legal community. Unless states with legalized cannabis programs have amended their state rules of professional conduct or provided advisory opinions on the matter, local attorneys assume a great deal of risk when representing clients within the cannabis industry.

To further complicate matters, what happens when a lawyer, who is licensed to …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

The Surprising Reach Of Fda Regulation Of Cannabis Even After Descheduling, Sean M. O'Connor, Erika Lietzan

American University Law Review

No abstract provided.

Ships In The Night: Resolving Administrative Conflict Between Fda- And Patent-Related Legislation, Carlos Garcia, Jonathan Stroud

American University Law Review

No abstract provided.

The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite

Articles

On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …